MAUDE Adverse Event Report: ABBOTT VASCULAR MITRACLIP SYSTEM CLIP DELIVERY SYSTEM; VALVE REPAIR

Catalog Number UNK CDS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Stroke/CVA (1770); Hemorrhage/Bleeding (1888); Ischemia (1942); Pericardial Effusion (3271); Heart Failure/Congestive Heart Failure (4446)

Event Date 01/01/2009

Event Type  Injury  

Manufacturer Narrative

Date of event - estimated.The unique device identifier (udi) is unknown because the part and lot numbers were not provided.The clips remain in the patients.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.The other patient/device effects mentioned in b5 and in the article are filed under different medwatch mfr numbers attachment: literature title : mitraclip therapy in daily clinical practice: initial results from the german transcatheter mitral valve interventions (trami) registry.

Event Description

This is filed to report the serious injuries.It was reported through a research article identifying mitraclip that may be related to the following: patient deaths, stroke, ischemia, pericardial effusion, heart failure, bleeding, medical intervention, mitral valve replacement, and hospitalization.Device issues include, single leaflet device attachment (slda) and inability to grasp the leaflets.Details are listed in the attached article, titled ¿mitraclip therapy in daily clinical practice: initial results from the german transcatheter mitral valve interventions (trami) registry.¿ please see article for additional information.

Manufacturer Narrative

The devices were not returned for analysis.A review of the lot history records and the similar complaint review could not be performed as the part and lot information regarding the complaint devices were not provided.The reported patient effects of ischemia, pericardial effusion, stroke (cerebrovascular accident), heart failure, and hemorrhage as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.Additionally, a cause for the ischemia, pericardial effusion, cerebrovascular accident, heart failure, hemorrhage and death, cannot be determined.The reported additional therapy/non-surgical treatment (unexpected medical intervention), surgical intervention and hospitalization were a result of case-specific circumstances.There is no indication of a product issue with respect to manufacture, design or labeling.

• Brand Name: MITRACLIP SYSTEM CLIP DELIVERY SYSTEM
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 11467580
• MDR Text Key: 240404472
• Report Number: 2024168-2021-01964
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 04/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK CDS
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/17/2021
• Initial Date FDA Received: 03/11/2021
• Supplement Dates Manufacturer Received: 04/02/2021
• Supplement Dates FDA Received: 04/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 75 YR